e — Class II medical device recall Z-0208-2016
Terminated recall by Siemens Medical Solutions USA, Inc., reported 2015-11-11, distributed nationwide. Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design o
| Recall number | Z-0208-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, United States |
| Recall initiated | 2015-06-26 |
| Classified | 2015-11-04 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HR, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LK, LU, LV, MA, MX, MY, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, QA, RS, SA, SE, SK, SV, TH, TN, TR, TW, UA, ZA |
| Quantity | 32,296 e.cam |
| Serial numbers | 10000, 100003, 10001, 10002, 10003, 10004, 10005, 10006, 10007, 10008, 10009, 1001, 10010, 10011, 10012, 10013, 10014, 10015, 10016, 10017, 10018, 10019, 1002, 10020, 10022 and 475 more |
Product
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Reason for recall
Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0208-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.